Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Validation engineer carries out a variety of tasks related to the validation of equipment and facilities.
The scope of activities include the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements
- The Validation Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others. The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
- Prepare validation documents
- Execution of IQ/OQ and PQ for equipment, systems and utilities.
- Write reports of completed validation activities
- Work to identify efficiencies in the validation program approach. Work to apply lessons learned, and stay informed of industry regulatory changes as it applies to equipment / facility validation.
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non Conformities, and CAPA’s.
- Writing and/or revising procedures applicable to the Engineering activities.
- Support the Engineering group to prepare the validation, requalification and maintenance program.
- Bachelor or Master in Biotech, Science, Technical or relevant;
- Experience with execution of IQ/OQ and PQ for equipment, systems and utilities;
- Proven knowledge and experience with validation documentation deliverables as URS,DQ,FMEA and Risk Assessments;
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.